By Fineline Cube 
Zhangzhou Pien Tze Huang Pharmaceutical Co., Ltd. (SHA: 600436) announced the enrollment of the first patient in a Phase IIa clinical trial for PZH2108 tablets, a Class 1 innovative chemical drug intended for the treatment of cancer pain.
Clinical Trial Milestone
| Item | Detail |
|---|---|
| Product | PZH2108 tablets |
| Company | Zhangzhou Pien Tze Huang Pharmaceutical (SHA: 600436) |
| Trial Phase | Phase IIa |
| Indication | Cancer pain |
| Study Design | Multi‑center, randomized, double‑blind, placebo‑controlled |
| Primary Endpoint | Treatment‑emergent adverse events (TEAEs) and abnormal safety assessments |
| Leading Institution | Henan Cancer Hospital (Medical Ethics Committee approved) |
| First Enrollment | 14 Nov 2025 |
| Next Step | Full patient enrollment targeted for Q3 2026 |
Drug Profile
- Class: Class 1 innovative chemical drug (novel molecular entity)
- Mechanism: Under evaluation; preclinical data suggest central/peripheral analgesic pathway modulation distinct from opioids
- Innovation: First oncology supportive care asset in Pien Tze Huang’s pipeline; addresses unmet need for non‑opioid cancer pain therapies in China
- Market Gap: Current options limited to opioids and NSAIDs, carrying addiction and GI bleeding risks; PZH2108 aims to provide improved safety profile
Market Context & Outlook
| Metric | Value |
|---|---|
| China Cancer Pain Patients | ~2.8 million (2024) |
| Current Treatment Paradigm | Opioids (70% share), NSAIDs (25%), adjuvants (5%) |
| Cancer Pain Market Size | ¥12 billion (US$1.6 billion) |
| Growth CAGR | 8% (2024‑2030) |
| Revenue Forecast (PZH2108) | ¥800 million‑1.2 billion (US$110‑160 million) peak sales by 2032 |
| Market Share Target | 8‑12% of moderate‑to‑severe cancer pain segment |
- Competitive Landscape: No novel non‑opioid cancer pain drugs approved in China since 2018; AstraZeneca’s naloxegol and Pfizer’s tapentadol address opioid‑induced side effects but not underlying pain mechanism
- Next Catalysts: Phase IIa safety data expected Q1 2027; Phase IIb dosing study initiation H2 2027 if safety profile is favorable
- Regulatory Path: BTD eligibility likely if Phase IIb demonstrates superior efficacy vs. standard of care
Forward‑Looking Statements
This brief contains forward‑looking statements regarding PZH2108’s clinical development, regulatory pathway, and market potential. Actual results may differ materially due to risks including clinical trial outcomes, safety profiles, and competitive dynamics in the cancer pain market.-Fineline Info & Tech